Scynexis Presents P-III (CANDLE) Study Results of Ibrexafungerp for the Prevention of Recurrent Vaginal Yeast Infections at IDSOG 2022


The P-III (CANDLE) study evaluating ibrexafungerp (300mg, BID) vs PBO in 260 female patients with RVVC. Patients initially received a 3-day regimen of fluconazole
The trial met its 1EPs i.e., 65.4% vs 53.1% of patients achieved clinical success with no recurrence at all either culture-proven, presumed, or suspected who received monthly single-day ibrexafungerp @24wks., superiority over PBO in 1EPs & 2EPs incl. no mycologically proven recurrence in 70.8%
In ITT & mITT population, 71% & 80% achieved a reduction or elimination of signs & symptoms, were safe & well-tolerated with no serious drug-related AEs, and no patients discontinued therapy due to AEs. The US FDA will review the sNDA of Brexafemme for an additional indication to prevent RVCC on Nov 30, 2022